Idiopathic Pulmonary Fibrosis Clinical Trial
Official title:
PhIb, Randomised, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability, and PK of an i.v. mAb After Single Ascending Doses in Subjects Affected by Idiopathic Pulmonary Fibrosis.
The purpose of this study is to assess the safety of CHF10067 (the study drug) and any side effects that might be associated with it. In addition, the study will evaluate how much of the study drug gets into the bloodstream and how long the body takes to remove it. The body's immune response to the study drug will also be evaluated. The study may also evaluate the effect of the study drug on the level of a certain protein in the body. Chiesi is conducting this study on patients affected by idiopathic pulmonary fibrosis (IPF, a lung disease). Chiesi is doing this study to establish the doses suitable for future studies.
The principal aim of this study is to obtain safety and tolerability data when CHF10067 is administered intravenously as single ascending doses to subjects with IPF. This information, together with the pharmacokinetic (PK) and immunogenicity data, will help establish the doses suitable for future studies in subjects. The effect of CHF10067 on TG2 levels will also be investigated as an exploratory endpoint. A sequential group, single ascending dose design has been chosen for safety reasons because CHF10067 is in the early stages of clinical development and no data in the IPF population has been collected so far. In addition, sentinel dosing will be used so that in each cohort 2 subjects (1 CHF10067 and 1 placebo) will be dosed at least 24 hours before the remaining 6 subjects. The study will be double-blind and placebo-controlled to avoid bias in the collection and evaluation of data during its conduct. Placebo has been chosen as the comparison treatment to assess whether any observed effects are treatment-related or simply reflect the study conditions. ;
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